(14 days)
ImageGrid Radiology Viewer System™ is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations.
Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed Mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.
ImageGrid Radiology Viewer System™ is a client/server software application that is designed to be used with the ImageGrid PACS device or as an independent service. The ImageGrid Radiology Viewer System™ can query, retrieve, and display medical images that it retrieves from a DICOM SCP. The device is a client/server software service that permits concurrent access to the ImageGrid PACS' medical images.
The provided text is a 510(k) summary for the "ImageGrid Radiology Viewer System™", a Picture Archiving Communications System (PACS). It describes the device, its indications for use, and a general statement about testing.
However, the document does not provide specific acceptance criteria or details of a study with quantitative results, sample sizes, expert qualifications, or ground truth methods that would allow for a complete answer to the request. The "Testing" section broadly states that "The complete system configuration has been assessed and tested at the factory and the device has passed all in-house testing criteria without significant failures." This is a general statement about internal validation rather than a detailed performance study suitable for evaluating specific acceptance criteria for AI or diagnostic performance.
Based on the provided text, I cannot complete the requested information for the following reasons:
- No specific acceptance criteria are listed. The document does not define measurable thresholds for performance metrics (e.g., accuracy, sensitivity, specificity, or image display quality) that the device must meet.
- No detailed study is presented. There is no mention of a formal clinical or technical study with a defined methodology, test set, ground truth, or statistical analysis.
- The device is a PACS viewer, not an AI diagnostic tool. The text explicitly states: "Diagnosis is not performed by the software but by Radiologists. Clinicians and referring Physicians as an adjunctive to standard radiology practices for diagnosis." Therefore, questions related to AI-specific performance metrics, multi-reader multi-case studies with AI assistance, or standalone AI performance are not applicable to this device as described.
Attempted Answer based on the absence of information in the provided text:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Not specified in the document. The document mentions "all in-house testing criteria" and "functional requirements specified in the SRS and User Manual," but does not list specific, quantifiable acceptance criteria (e.g., display accuracy metrics, data transfer integrity, uptime).* "The complete system configuration has been assessed and tested at the factory and the device has passed all in-house testing criteria without significant failures."
"The data presented ... demonstrates that the ImageGrid Radiology Viewer System performs all required actions according to the functional requirements specified in the SRS and User Manual with no errors that had an impact on safety or efficacy." |
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The "in-house testing" implies internal data, but no details on origin (e.g., country, retrospective/prospective) are given.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The device is a viewer, not a diagnostic AI. The document does not describe a ground truth establishment process for diagnostic performance, as the software itself does not perform diagnosis.
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Adjudication method for the test set:
- Not applicable/Not specified.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The document does not mention any MRMC study. The device is a PACS viewer, not an AI to be used in conjunction with human readers in a comparative effectiveness study. The text explicitly states that diagnosis is performed by human professionals.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a PACS viewer and is not intended to provide standalone diagnostic performance or an "algorithm only" interpretation. Its function is to display images for human interpretation.
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The type of ground truth used:
- Not applicable. As a PACS viewer, its primary function is display and communication, not independent diagnosis where a "ground truth" for disease presence/absence would be established for algorithm performance.
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The sample size for the training set:
- Not applicable. As a software application for image viewing and communication without an AI diagnostic algorithm, there would not be a "training set" in the context of machine learning.
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How the ground truth for the training set was established:
- Not applicable (no training set for an AI model).
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).